DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 12/15/22 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
Election/Restrictions
3. Applicant’s election, without traverse, of Group I, in the reply filed on 10/20/25, is acknowledged.
Claim Status
4. The amendment, filed 10/20/25, has been entered.
5. Claims 1-11, 13-14, and 16 are pending. Claims 12 and 15 are cancelled. Claims 11, 13, and 16 are amended. Claims 11, 13-14, and 16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/20/25. Claims 1-10 are under examination.
Claim Interpretation
6. In the interest of compact prosecution, it is noted that:
SEQ ID NO: 2 is a sequence of 430 amino acids that are identical to the amino acid sequence found in naturally occurring SEQ ID NO: 1 with the notable exception of an unnatural substitution of the asparagine (i.e. Asn; N) amino acid at residue 406 of SEQ ID NO: 1 for an isoleucine (i.e. Ile; I) amino acid in SEQ ID NO: 2.
Consequently, SEQ ID NO: 2 is markedly different from its naturally occurring counterpart.
Claim Objections
7. Claims 5, 6, 9 and 10 are each objected to because of the following informalities: format. Each of these claims contains an extra space between the last word of the sentence and the period suggesting additional text may have been meant to be added. Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
9. Claims 2-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The phrase “”involved in” in claim 2, part c is a relative term which renders the claim indefinite. The phrase “involved in” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, how much (i.e. to what degree of) “involvement in” transcription termination and/or polyadenylation is required to be included vs. excluded in the claim scope? Thus, clarification is required.
Each of claims 7-10 recites the limitation "the yeast" in line 1. There is insufficient antecedent basis for this limitation in each claim because claim 4, from which each directly depends, does not recite “a yeast” but rather “a vector”. The limitation requiring the vector to be in a yeast host cell is not introduced until dependent claim 5. Accordingly, clarification is required to ascertain the metes and bounds of these claims.
Other dependent claims do not clarify issues identified above; accordingly, clarification is require to remove scope ambiguity.
Claim Rejections - 35 USC § 112
10. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
11. Claims 2-10 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Instant claims are drawn to a chimeric gene comprising the following operatively linked elements: (a) a promoter which is active in a eukaryotic cell; (b) a nucleic acid molecule encoding an amino acid sequence with a sequence identity of at least 90% to SEQ ID No.1, wherein the amino acid sequence comprises an isoleucine residue at a position corresponding to position 406 of SEQ ID No. 1; and (c) 3’ end region involved in transcription termination and/or polyadenylation (see claim 1); and yeast comprising the gene and a nucleic acid molecule encoding an amino acid sequence with sequence identity of at least 90% to SEQ ID No. 3, wherein the amino acid sequence comprises an isoleucine residue at a position corresponding to position 405 of SEQ ID No. 3 (see claims 4, 5, 6 and 8). Consequently, it is the Office’s position that (1) the independent claim constitutes a "broad generic claim” based on the lack of guidance regarding the actual structures required (i.e. the nucleic acid is claimed only by its functional ability to encode something else, but is not actually claimed by any required structure per se); and the generically claimed “yeast”; and (2) the claimed genus has substantial variation because of the numerous alternatives permitted.
However, with regards to the nucleic acids, the specification does not provide adequate written description to identify the broad genus of the claims because, inter alia, the claims do not include a correlation between the necessary structure of the nucleic acid molecule (i.e. its sequence of nucleotides), and the claimed function to be maintained (i.e. encoding an amino acid sequence with as little as 90% similarity to SEQ ID NO: 1 and/or 3 each with a particular substitution). Further, the specification does not adequately describe 3 prime end regions involved in transcription termination and or 3 prime end regions involved in polyadenylation (i.e. how much or how little would constitute a “region” and to what degree of “involvement” is required?).
Therefore, the claims do not define structural features commonly possessed by members of the genus, and thus do not distinguish the members thereof, except by function. However, while the description of an ability of a claimed nucleic acid molecule may generically describe that molecule's function, it does not describe the molecule itself. Thus, a definition by function does not suffice to define the genus because it is only an indication of what the nucleic acid molecule does, rather than what it is; therefore, it is only a definition of a useful result rather than a definition of what achieves that result. In addition, because the genus of nucleic acid molecules is highly variable (see MPEP 2434), the functional property of encoding something else and/or mere involvement in particular processes, is insufficient to describe the genus. Thus, the specification does not provide substantive evidence for possession of this large and variable genus, encompassing a potentially massive number of nucleotide sequences, claimed only their functional characteristics of encoding partial structures (e.g. 90% sequence variants of SEQ ID 1 and/or 3) and/or the poorly described “regions” that are “involvement in” transcription termination and/or polyadenylation.
Further, MPEP §2163 states that if a biomolecule is described only by a functional characteristic (as in the instant case), without any disclosed correlation between function and structure of the sequence (as in the instant case), it is not sufficient for written description purposes, even when accompanied by a method of obtaining the claimed sequences. MPEP §2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance (as in the instant case), the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number to adequately describe a broad genus. The courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus (e.g. see In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618). Furthermore, the disclosure of only one or two species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]; emphasis added. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). In the instant case, there are no nucleic acid molecules described for 90% sequence variants of either SEQ ID NO: 1 or 3, or for the regions of genes being involved in the claimed processes. Accordingly, the specification also does not provide adequate written description to identify the broad genus of the claims, claimed only by functional characteristics and by not structures per se, because inter alia, it does not describe a sufficient number and/or a sufficient variety of representative species to reflect the breadth and variation within the entire claimed genus.
In addition, with regards to the yeast, the specification adequately describes the use of Saccharomyces cerevisiae (see Figure 11) but not does not adequately describe other yeast nor a nexus to any other yeast, in general (see claim 5), or xylose fermenting yeast, in particular (see claim 6). By extension, the specification does not adequately describe the generically claimed yeast in a pure culture (see claim 9) or in a culture comprising lignocellulosic hydrolysates (see claim 10). Likewise, the specification does not adequately describe wherein the yeast is able to metabolize lignocellulosic hydrolysates comprising one or more growth inhibiting compounds selected from the group consisting of hydroxymethylfurfural, furfural, formic acid, acetic acid, levulinic acid, 4-hydroxybenzoic acid, 4-hydroxybenzaldehyde, and vanillin (see claim 7). The specification appears to describe some non-conventional yeasts, but it is unclear, which, if any has the corresponding nucleic acids with the claimed mutation (see Figures 2, 5, 6, 8 and 9; and Table 1).
Consequently, based on the lack of information within the specification, there is evidence that a representative number and a representative variety of the numerous yeast species combined with the distinct partial structures of nucleic acid molecules, have not yet been identified and thus the specification represents little more than a wish for possession; See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Therefore, it is the Office’s position that even one of skill in the art would not conclude that Applicant was in possession of the entire broad and highly variable genus claimed.
With regards to the state of the art, and given the highly diverse nature of nucleic acid molecules, even one of skill in this art cannot envision the structure of a corresponding nucleotide sequence by only knowing what it encodes, as evidenced by the art, for example, see Edelman et al. 2001 (Degeneracy and complexity in biological systems; PNAS 98(24): 13763-13768). In summary, a specific protein sequence is easily determined from a known nucleic acid sequence, because the known sequence of nucleotides (i.e. a nucleic acid sequence) produces one and only one corresponding protein sequence (i.e. a sequence of amino acids); but, the inverse is not true because a specific sequence of nucleotides cannot be ascertained from a known sequence of amino acids since more than one distinct codon (i.e. set of three nucleotides) may code for a particular amino acid. Thus, a description of the amino acid per se, does not provide sufficient written description of the codon encoding that amino acid because the one-to-one correspondence is unidirectional, i.e., from codon forward to amino acid, but not from amino acid back-translated to codon. Thus, the specification does not adequately describe any of the structures of the numerous nucleic acid sequences claimed by their capacity to encode the claimed protein sequence, especially only the partial structures thereof (i.e. 90% sequence variants for SEQ ID NO: 1 and 3).
With regards to the yeast, Villarreal et al. 2025 (Non-Conventional Yeasts as a Source of Genetic Diversity and Biotechnological Potential; Annual Review of Microbiology 79:595-614) teaches the state of the art regarding using yeast as a biotechnological platform is still under development and thus necessarily unpredictable (even after the effective filing date of the instant application). For example, Villarreal questions the ability of Saccharomyces cerevisiae to represent the knowledge base with regards the vast array of other yeast species (e.g. see abstract and the introduction). Villarreal teaches there are approximately 2,000 yeast species distributed across two main phyla and acknowledges that “we are likely aware of a minor fraction of the total yeast diversity because only about 1% of microorganisms are cultivable, and the estimated total number of yeast species might reach 200,000…” (see pages 596-7). Villarreal teaches the non-Saccharomyces cerevisiae yeasts (called NCYs) represent diverse microorganisms with unknown potential for sustainable biotechnological applications and are not represented by S. cerevisiae (page 597 and Figure 1). Villarreal concludes that despite growing interest in NCYs, significant limitations hinder a full exploration of their genetic potential and biotechnological applications because a primary challenge is that, to fully understand the ecology and the adaptative mechanisms across different NCYs, several isolates from different habitats, latitudes, and environments per species (or genus) are still needed; and that the lack of well-developed genetic tools and protocols might hamper the study of these species and limit our understanding of their genetic and phenotypic traits, such that future research should prioritize bioprospecting studies, including the development of broader growth conditions and of novel molecular tools that could facilitate precise laboratory manipulations (e.g. see page 603).
Further, Thevelein et al. 2016 (WO 2016/083397 A1; of record) teaches hydrolysates of lignocellulose are an interesting source for the production of bioethanol but that several problems exist, including the presence of toxic compounds such as acetic acid, furfural and lignin derivatives (see page 1).
Therefore, the state of the art, does not provide adequate written description for which nucleic acid molecules back-translated from which 90% amino acid sequence variants would predictably and reliably function in which yeast and thereby retain the ability to metabolize lignocellulosic hydrolysates comprising one or more growth inhibiting compounds selected from the group consisting of hydroxymethylfurfural, furfural, formic acid, acetic acid, levulinic acid, 4-hydroxybenzoic acid, 4-hydroxybenzaldehyde, and vanillin, as claimed.
Consequently, neither the specification nor the state of the art provides sufficient written description to support the genus encompassed by the claims. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.).
Therefore, given the above analysis of the factors as a whole, which the courts have determined are critical in determining whether Applicant is in possession of, or the specification supports, the claimed invention, Applicant has not satisfied the requirements as set forth under 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112
11. Claims 2-10 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for nucleic acid molecules encoding SEQ ID NO: 2 alone and/or comprised in Saccharomyces cerevisiae; the specification does not reasonably provide enablement for 90% nucleic acid sequence variants alone or expressed in all species of yeast. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
Factors to be considered in determining whether undue experimentation is required, are set forth in In re Wands, 8 USPQ2d 1400. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and (8) the breadth of the claims. Although all the factors were considered, the most relevant ones are discussed below. In the instant case:
Nature of the invention: The nature of the invention is a chimeric gene comprising (a) a promoter which is active in a eukaryotic cell; (b) a nucleic acid molecule encoding an amino acid sequence with a sequence identity of at least 90% to SEQ ID No.1, wherein the amino acid sequence comprises an isoleucine residue at a position corresponding to position 406 of SEQ ID No. 1; and (c) 3’ end region involved in transcription termination and/or polyadenylation; and yeast comprising the gene and a nucleic acid molecule encoding an amino acid sequence with sequence identity of at least 90% to SEQ ID No. 3, wherein the amino acid sequence comprises an isoleucine residue at a position corresponding to position 405 of SEQ ID No. 3.
Therefore, the nature of the invention is a chemical case, where there is natural unpredictability in performance of certain species or sub-combinations other than those specifically enumerated; see MPEP 2163. Accordingly, it is the Office’s position that undue experimentation would be required to practice the full scope of the claimed invention, with a reasonable expectation of success, because it would not be predictable from the disclosure of one particular species what other species may or may not work; see MPEP 2164.03. In the instant case, there are no nucleic acid molecules disclosed that encode SEQ ID NO: 1 or 3 or 90% variants thereof, and only one species of yeast (Saccharomyces cerevisiae).
Breadth of the claims: The broadest reasonable interpretation of the claims covers numerous nucleic acid molecules claimed only by functional characteristics (i.e. nucleic acid molecules that must be back-translated from partial structures of 90% amino acid sequence variants) alone and/or comprised in thousands of different and distinct yeast species while maintaining the ability of the yeast to metabolize lignocellulosic hydrolysates comprising hydroxymethylfurfural, furfural, formic acid, acetic acid, levulinic acid, 4-hydroxybenzoic acid, 4-hydroxybenzaldehyde, and/or vanillin. However, without guidance on which of the structural components are required (i.e. what polynucleotides are required; and/or which of the 90% of the amino acids must be conserved; and/or which yeast) to maintain their claimed functions (see above); undue experimentation would be required to determine which of the structures (i.e. which sequence variants and/or which yeast) actually work, and thereby carry out the full scope of the invention as claimed. Accordingly, undue experimentation would be required to practice the full scope of the claimed invention, with a reasonable expectation of success, because while enablement is not precluded by the necessity for routine screening, if a large amount of screening is required, the specification must provide a reasonable amount of guidance with respect to the direction in which the experimentation should proceed and such guidance has not been provided in the instant specification.
Amount of Direction Provided by Inventor and Existence of Working Examples: The specification provides complete structural information for SEQ ID NO: 1 and 3 (i.e. amino acid sequences) alone and comprised in Saccharomyces cerevisiae; however, the claims also encompass partial structures thereof (i.e. 90% sequence variants) subsequently back-translated into nucleic acid molecules, alone and/or comprised in yeast host cells required to maintain the ability of the yeast to metabolize lignocellulosic hydrolysates comprising hydroxymethylfurfural, furfural, formic acid, acetic acid, levulinic acid, 4-hydroxybenzoic acid, 4-hydroxybenzaldehyde, and/or vanillin. Yet, there are no nucleic acid molecules sufficiently disclosed for 90% sequence variants of either SEQ ID NO: 1 or 3, or for any of the regions of genes being involved in the claimed processes of transcription termination or polyadenylation. In addition, with regards to the yeast, the specification discloses the use of Saccharomyces cerevisiae but not does not sufficiently disclose other yeast nor a nexus to any other yeast, in general, or xylose fermenting yeast, in particular. By extension, the specification does not sufficiently disclose those yeast in a pure culture or in a culture comprising lignocellulosic hydrolysates. Likewise, the specification does not sufficiently disclose wherein the generically claimed yeast is able to metabolize lignocellulosic hydrolysates comprising hydroxymethylfurfural, furfural, formic acid, acetic acid, levulinic acid, 4-hydroxybenzoic acid, 4-hydroxybenzaldehyde, and/or vanillin. The specification appears to disclose some non-conventional yeasts, but it is unclear, which, if any have the corresponding nucleic acids with the claimed mutation (see Figures 2, 5, 6, 8 and 9; and Table 1).
Accordingly, the scope of the claims is extremely broad compared to the guidance and exemplification provided in the specification and the specification fails to teach the necessary structure-function correlations and/or a representative number and variety of species (see rejection above). Thus, based on the numerous possibilities, it is the Office’s position that a non-routine amount of experimentation would be required to practice the full scope of the invention, with a reasonable expectation of success.
State of the Prior Art and Level of Predictability in the Art: With regards to the nucleic acid molecules, even one of skill in this art cannot envision the structure of a corresponding nucleotide sequence by only knowing what it encodes, as evidenced by the art, for example, see Edelman et al. 2001 (Degeneracy and complexity in biological systems; PNAS 98(24): 13763-13768). In summary, a specific protein sequence is easily determined from a known nucleic acid sequence, because the known sequence of nucleotides (i.e. a nucleic acid sequence) produces one and only one corresponding protein sequence (i.e. a sequence of amino acids); but, the inverse is not true because a specific sequence of nucleotides cannot be ascertained from a known sequence of amino acids since more than one distinct codon (i.e. set of three nucleotides) may code for a particular amino acid. Thus, a disclosure of the amino acid per se, does not provide enablement of the codon encoding that amino acid because the one-to-one correspondence is unidirectional, i.e., from codon forward to amino acid, but not from amino acid back-translated to codon. The correlation for sequence variants (i.e. the substituted amino acid is not identified) is even worse.
With regards to the yeast, Villarreal et al. 2025 (Non-Conventional Yeasts as a Source of Genetic Diversity and Biotechnological Potential; Annual Review of Microbiology 79:595-614) teaches the state of the art regarding using yeast as a biotechnological platform is still under development and thus necessarily unpredictable. For example, Villarreal questions the ability of Saccharomyces cerevisiae to represent the knowledge base with regards the vast array of other yeast species (e.g. see abstract and the introduction). Villarreal teaches there are approximately 2,000 yeast species distributed across two main phyla and acknowledges that “we are likely aware of a minor fraction of the total yeast diversity because only about 1% of microorganisms are cultivable, and the estimated total number of yeast species might reach 200,000…” (see pages 596-7). Villarreal teaches the non-Saccharomyces cerevisiae yeasts (called NCYs) represent diverse microorganisms with unknown potential for sustainable biotechnological applications and are not represented by S. cerevisiae (page 597 and Figure 1). Villarreal concludes that despite growing interest in NCYs, significant limitations hinder a full exploration of their genetic potential and biotechnological applications because a primary challenge is that, to fully understand the ecology and the adaptative mechanisms across different NCYs, several isolates from different habitats, latitudes, and environments per species (or genus) are still needed; and that the lack of well-developed genetic tools and protocols might hamper the study of these species and limit our understanding of their genetic and phenotypic traits, such that future research should prioritize bioprospecting studies, including the development of broader growth conditions and of novel molecular tools that could facilitate precise laboratory manipulations (e.g. see page 603). Furthermore, Thevelein et al. 2016 (WO 2016/083397 A1) teaches hydrolysates of lignocellulose are an interesting source for the production of bioethanol but that several problems exist, including the presence of toxic compounds such as acetic acid, furfural and lignin derivatives (see page 1).
Thus, the state of the art supports that the skilled artisan requires guidance on both the critical structures of the polynucleotide per se (e.g. its sequence and/or a highly specific sequence of amino acids to back-translate) and of the particular yeast host species. However, based on the astronomically vast number of polynucleotide sequences for partial structures of sequence variations coupled to the thousands of yeast species permitted, it is the Office’s position that testing that many possibilities easily rises to the level of excessive, and is thus non-routine and undue. Therefore, the full scope of the claims is not enabled because even the skilled artisan cannot make and use the invention, with a reasonable expectation of success, without an undue amount of experimentation first.
Relative Skill of Those in the Art: The relative level of skill of those in the art is deemed to be high (e.g. PhD level); however, even one of skill in the art could not predictably extrapolate the teachings in the specification, limited to an amino acid sequence as set forth in SEQ ID NO: 1 and/or 3 and having a particular sequence of amino acids, alone and/or comprised in Saccharomyces cerevisiae to all of the other corresponding polynucleotide sequences back-translated from amino acid sequences with as little as 90% similarity to SEQ ID NO: 1 and/or 3, alone and/or comprised in all other yeast host cells, as broadly as is claimed. The skilled artisan simply cannot envision the structures of the polynucleotides (alone or in combination with the yeast) required; thus, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method used to determine the polynucleotide sequences and/or yeast species, after the fact. Thus, one of skill in the art, given the art-recognized degeneracy of the universal genetic code, and the art-recognized diversity of yeast, would have to engage in undue experimentation to determine which polynucleotides encode which 90% sequence variants of SEQ ID NO: 1 and/or 3, either alone or in which yeast, to maintain the claimed functional properties of the ability to metabolize lignocellulosic hydrolysates comprising hydroxymethyl-furfural, furfural, formic acid, acetic acid, levulinic acid, 4-hydroxybenzoic acid, 4-hydroxybenzaldehyde, and vanillin; and thereby carry out the full scope of the invention as claimed.
Quantity of Experimentation Necessary Based on Content of the Disclosure: The specification does not enable the genus because where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims; In re Soil, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required; In re Fisher, 427 F.2d 833,839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity); see also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); and In re Vaeck, 947 F.2d 488,496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). Accordingly, without such guidance, the experimentation left to those skilled in the art is unnecessarily and improperly extensive and undue; See Amgen, Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F, 2d 1200, 18 USPQ 1016 (Fed. Cir. 1991) at 18 USPQ 1026 1027 and Exparte Forman, 230 USPQ 546 (BPAI 1986).
Therefore, in view of the lack of guidance and direction provided by Applicant, it is the Office’s position that there would be undue experimentation required to practice the full scope of the invention, with a reasonable expectation of success. Thus, Applicant has not satisfied the requirements as set forth under 35 U.S.C. 112(a).
Conclusion
12. Claim 1 is allowed.
13. Claims 2-10 are rejected.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on (571)-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
November 5, 2025